The following data is part of a premarket notification filed by Ortho Clinical Diagnostics with the FDA for Vitros Chemistry Products Cl- Slides.
| Device ID | K162020 |
| 510k Number | K162020 |
| Device Name: | VITROS Chemistry Products Cl- Slides |
| Classification | Electrode, Ion-specific, Chloride |
| Applicant | Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Contact | Marlene Hanna |
| Correspondent | Marlene Hanna Ortho Clinical Diagnostics 100 Indigo Creek Drive Rochester, NY 14626 |
| Product Code | CGZ |
| CFR Regulation Number | 862.1170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-21 |
| Decision Date | 2016-12-16 |
| Summary: | summary |